ACW at Sachs Neuroscience and JPM week in San Francisco
Released
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Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
1
ASX ANNOUNCEMENT
Actinogen seniormanagement conduct a seriesof meetings at the Sachs Neuroscience
InnovationForum & duringthe JP Morgan HealthcareConference weekin San Francisco
Sydney, 12 January 2026. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to
announce that four of its senior executives will conduct meetings today at the Sachs Associates 9th Annual
Neuroscience Innovation Forum in San Francisco (11 January USA PST). The Company’s CEO, Dr Steven
Gourlay and CMO, Dr Dana Hilt are joined in San Francisco by CFO, Will Souter, and CCO, Andrew Udell.
The Sachs Forum brings together pharmaceutical companies, analysts and investors who are focused on
neuroscience as a key component of their pipelines and portfolios. The audience includes buy- and sell-side
analysts from investment banks and funds, along with partnering executives from pharma, biotech, medtech,
neurotech, and diagnostics companies.
While in San Francisco, the ACW team will also participate in a significant number of partnering, analyst and
investor meetings associated with the 44th Annual J.P. Morgan Healthcare Conference from January 12 to 15,
2026 (“JPM Week”).
The information used for all Sachs Innovation Forum and JPM Week presentations and meetings is attached
to this announcement or has been previously announced.
The attached presentation summarises recent advances in the Xanamem Alzheimer’s disease program and
the multiple, independent clinical trials supporting the likelihood of success in the current XanaMIA pivotal trial.
The trial is due to report the outcome of its interim analysis in late January 2026 and final topline results in
November 2026.
CEO, Dr Steven Gourlay commented:
“Given the advanced stage of our XanaMIA trial, with the interim analysis in January and topline results in
November, there is a growing awareness of the potential of the Xanamem program to deliver a safe and
effective oral therapy for Alzheimer’s disease. The Sachs Neuroscience Forum represents a particularly good
opportunity to update the key industry players in neuroscience on our 2026 timeline.”
View this announcement on our InvestorHub: https://investors.actinogen.com.au/link/eol7pr
ENDS
Investors Media
Dr Steven Gourlay Michael Roberts George Hazim
CEO & Managing Director Investor Relations Media & Public Affairs Australia
P: +61 2 8964 7401 M: +61 423 866 231 M: +61 417 516 262
E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au E: georgehazim@mediaaffairs.com.au
Xanamem is a registered trademark of Actinogen Medical Limited
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
2
Announcement authorised by the Disclosure Committee of Actinogen Medical Limited
About Actinogen Medical
Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological and
neuropsychiatric diseases associated with dysregulated brain cortisol.There is a strong association between cortisol and
detrimental changes in the brain, affecting cognitive function, harm to brain cells and long-term cognitive health.
Cognitive function means how a person understands,remembers and thinks clearly.Cognitive functions include memory,
attention, reasoning, awareness and decision-making.
Actinogen is currently developing its lead compound, Xanamem, as a promising new therapy for Alzheimer’s Disease. It
has also conducted a phase 2 trial in patients with cognitive impairmentand depression andmay study Fragile X Syndrome
and other neurological and psychiatric diseases in the future. Reducing cortisol inside brain cells could have a positive
impactin these and many other diseases.The cognitive dysfunction,behavioural abnormalities,and neuropsychological
burden associated with these conditions is debilitating for patients,and there is a substantial unmetmedical need for new
and improved treatments.
Clinical Trials
The XanaMIA Phase 2b/3 Alzheimer’s disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel
group design trial in 220 patients with mild to moderate AD and progressive disease, determined by clinical criteria and
confirmed by an elevated level of the pTau181 protein biomarker in blood.Patients receive Xanamem 10 mg or placebo,
once daily,and its ability to slow progression of Alzheimer’s disease is assessed with a variety of endpoints.The primary
endpointof the trial is the internationally-recognized CDR-SB (Clinical Dementia Rating scale – Sum of Boxes). The trial
is being conducted in Australia and the US.The trial is now closed to recruitment,with initial results from an interim analysis
expected in late January 2026 and final topline results in November 2026.
The XanaMIA-OLE Alzheimer’s disease open-label extension is an open-label phase of up to 25 months treatment
where all participants will receive active Xanamem 10 mg once daily.The trial will evaluate safety and a limited number of
efficacy endpoints such as the CDR-SB. The trial will commence in Q1 2026 and be open to all former and current
participants in the XanaMIA Phase 2b/3 trial.
The XanaCIDD Phase 2a depression trial was a double-blind, six-week proof-of-concept, placebo-controlled, parallel
group design trial in 167 patients with moderate, treatment-resistant depression and a degree of baseline cognitive
impairment. Participants were evenly randomized to receive Xanamem 10 mg once daily or placebo, in most cases in
addition to their existing antidepressanttherapy,and effects on cognition and depressionwere assessed.Trial results were
reported in August 2024 and showed clinically and statistically significantbenefits on depression symptoms with positive
effects on the MADRS scale (a validated scale of depression symptom measurement) and the PGI-S (a valid patient
reported assessmentof depression severity). Cognition improved markedly and to a similar extent in both Xanamem and
placebo groups.
About Xanamem (emestedastat)
Xanamem’s novel mechanism is to control elevated levels of cortisol (aka the “stress hormone”) in the brain through the
inhibition of the cortisol synthesis enzyme,11β-HSD1,withoutaffecting production of cortisol by the adrenal glands which
is essential for the body’s normal functioning.Xanamem is a first-in-class,once-a-day pill designed to deliver high levels
of cortisol control in key areas of the brain related to Alzheimer’s and other diseases such as the hippocampus and frontal
cortex. To view Xanamem’s two-minute Mechanism of Action animation, click here.
Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be
toxic to brain cells. Cortisol itself is also associated with depressive symptoms and when targeted via other mechanisms
has shown some promise in prior clinical trials. The recent XanaCIDD trial demonstrated clinically and sometimes
statistically significant benefits on depressive symptoms, further validating the cortisol control mechanism for the
Xanamem 10 mg oral daily dose.
The Company has studied 11β-HSD1 inhibition by Xanamem in approximately 400 volunteers and patients in eightclinical
trials. Xanamem has a promising safety profile and has demonstrated clinical activity in patients with depression,patients
with biomarker-positive Alzheimer’s disease and cognitively normal volunteers. High levels of target engagement in the
brain with doses as low as 5 mg daily have been demonstrated in a human PET imaging study.
Actinogen Medical Limited ACN 086 778 476
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000
+61 2 8964 7401 | actinogen.com.au
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Xanamem is an investigational productand is not approved for use outside of a clinical trial by the FDA or by any global
regulatory authority. Xanamem® is a trademark of Actinogen Medical.
Disclaimer
This announcement and attachments may contain certain "forward-looking statements" that are not historical facts; are
based on subjective estimates,assumptions andqualifications;and relate to circumstances and events thathave nottaken
place and may nottake place.Such forward looking statements should be considered “at-risk statements” - notto be relied
upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business,
economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes
and uncertainties) that may lead to actual results being materially different from any forward looking statement or the
performance expressed or implied by such forward looking statements.You are cautioned not to place undue reliance on
these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any
obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to
reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future
performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of
achievementor reasonableness of any forward-looking statements and there can be no assurance or guarantee that any
forward-looking statements will be realised.
ACTINOGEN MEDICAL ENCOURAGES ALL CURRENT INVESTORS TO GO PAPERLESS BY REGISTERING THEIR DETAILS
WITH THE DESIGNATED REGISTRY SERVICE PROVIDER, AUTOMIC GROUP.
Oral Xanamem®
Controlling brain cortisol to slow progression in Alzheimer’s disease
and treat depression
Sachs Neuroscience Innovation Forum & JPM week
Dr Steve Gourlay, CEO; Dr Dana Hilt, CMO; Mr Andy Udell, CCO; Mr Will Souter, CFO
11 – 15 January 2026
® Xanamem is a registered trademark of Actinogen Medical Limited
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This presentation has been prepared by Actinogen Medical Limited. (“Actinogen” or the “Company”) based on information available to it as at the date of this presentation. The information in this presentation is provided in summary form and
does not contain all information necessary to make an investment decision.
This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in Actinogen, nor does it constitute financial product advice or take into account any individual’s
investment objectives, taxation situation, financial situation or needs. An investor must not act on the basis of any matter contained in this presentation but must make its own assessment of Actinogen and conduct its own investigations.
Before making an investment decision, investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs, and seek legal, taxation and financial advice appropriate to their
jurisdiction and circumstances. Actinogen is not licensed to provide financial product advice in respect of its securities or any other financial products. Cooling off rights do not apply to the acquisition of Actinogen securities.
Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the
fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of Actinogen its officers, directors, employees and agents, nor any
other person, accepts any responsibility and liability for the content of this presentation including, without limitation, any liability arising from fault or negligence, for any loss arising from the use of or reliance on any of the information
contained in this presentation or otherwise arising in connection with it.
The information presented in this presentation is subject to change without notice and Actinogen does not have any responsibility or obligation to inform you of any matter arising or coming to their notice, after the date of this presentation,
which may affect any matter referred to in this presentation.
This presentation is not for general distribution or third party reliance or use.
This presentation contains certain budget information, forecasts and forward looking statements that are based on the Company’s management’s beliefs, assumptions and expectations and on information currently available to management
in respect of which there is NO guarantee of future performance. Such budget information, forecasts and forward looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results or
performance of Actinogen to be materially different from the results or performance expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to the performance of Actinogen in its
clinical trials including whether it's technology proves to be a safe and effective treatment, market penetration, competition from any other similar products, intellectual property risks (including securing rights in technology and patents) and
global economic conditions. Furthermore, Actinogen's research, product development, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. There is
no guarantee that Actinogen will obtain the required approvals, licences and registrations from the relevant authorities in jurisdictions in which it operates. Actinogen or others could identify product and efficacy issues relating to the safety of
our technology. Accordingly, all forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the political and economic environment in which Actinogen will operate in
the future, which are subject to change without notice. Past performance is not necessarily a guide to future performance and no representation or warranty is made as to the likelihood of achievement or reasonableness of any forward
looking statements or other forecast. There is no guarantee that Actinogen will achieve its stated objectives/milestones, that any of its forecasts will be met or that forward looking statements will be realised. You are cautioned not to place
undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of or non-occurrence of any events.
Neither Actinogen nor any other entity or person in or associated with Actinogen guarantee any return (whether capital or income) or generally the performance of Actinogen or the price at which its securities may trade. Any investment in
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To the maximum extent permitted at law, Actinogen and all of its representatives, directors, officers, partners, employees or professional advisers (Parties) exclude all direct and indirect liability arising out of or in connection with any use or
reliance of the information contained or described within this presentation. Other than to the extent required by law (and only to that extent), the Parties do not make any representation or give any assurance, guarantee or warranty (express
or implied) as to, nor assume any responsibility or liability for, the authenticity, origin, validity, accuracy, suitability or completeness of, or any errors in or omissions from, any information, statement or opinion contained in this presentation or
any accompanying, previous or subsequent material or presentation.
Disclaimer
Sachs NIF & JPM week presentation January 2026
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Management Team
Experience & track record matters
Board of Directors
Dr. Geoff Brooke
Chairman
MBBS; MBA
Dr. Steven Gourlay
CEO & MD
MBBS; FRACP; PhD; MBA
Mr. Malcolm McComas
Non-Executive Director
BEc, LLB; FAICD; SF Fin
Dr. George Morstyn
Non-Executive Director
MBBS; PhD; FRACP CD
Dr. Nicki Vasquez
Non-Executive Director
PhD
Dr. Dana Hilt
Chief Medical Officer
MD
Dr. Steven Gourlay
CEO & MD
Will Souter
Chief Financial Officer
BComm, LLB
Andrew Udell
Chief Commercial Officer
MBA
Cheryl Townsend
VP Clinical Operations
RN, M Health Law
Fujun Li
Head of Manufacturing
PhD
Michael Roberts
Head of IR & Comms
B.Ec (Hons), CPA, FFIN
Sachs NIF & JPM week presentation January 2026 3
Alzheimer’s disease market is large and growing
4
Growing Alzheimer’s Disease market – U.S.
Large, unsatisfied and growing market
Sachs NIF & JPM week presentation January 2026
Xanamem’s unique mechanism of action
5
Click here for animation video
Sachs NIF & JPM week presentation January 2026
Xanamem has a clear path to Alzheimer’s approval
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• Recent FDA agreement confirms development pathway to US marketing approval using
one additional pivotal trial of 10 mg vs. placebo and open-label safety studies
• Clear guidance on manufacturing, ancillary studies
• Ongoing XanaMIA pivotal clinical trial:
• Full enrolment in US and Australia
• Excellent safety profile maintained, positive first Data Monitoring Committee review
• Interim analysis of safety and efficacy futility in late Jan 2026 using all available data
• On-track for final results in November 2026
• Phase 3 planning commencing in parallel with discussions re potential partnerships
Phase 2b/3 trial on track, FDA agreement streamlines development, EMA meeting 2026
Sachs NIF & JPM week presentation January 2026
Highlights of Alzheimer’s treatment landscape
Oral Xanamem is leading the charge with a potential game-changing new mechanism
Mechanistic Admin Comments
Older drugs - boosting acetylcholine or
glutamate
Oral Marketed since '90s/'00s, symptomatic only. Gastrointestinal side
effects.
Anti-amyloid protein immunotherapies IV/SubQ Marketed with challenges including variable reimbursement (e.g. not
Aust.). Safety concerns including infusion reactions, brain swelling /
bleeding - MRI monitoring required
Second-gen anti-amyloid with “brain shuttle” IV/SubQ Late-stage trials e.g. Roche’s trontinemab. Likely to be safer than
first-gen due to less binding to vascular wall amyloid
Xanamem (emestedastat) control of
elevated brain cortisol
Oral Mid-first pivotal, phase 2b/3 trial. Promising: n~500, can be
combined with older drugs. Once daily dosing
Blarcamesine SIGMAR1 antagonist to block
autophagy
Oral One phase 2b/3 trial, regulatory approval recently rejected by EMA.
Dizziness, increased rate serious side effects vs. placebo
Anti-amyloid formation or toxicity Oral Most failed phase 2, some on-going trials in patient subgroups.
Anti-tau protein immunotherapy IV/SubQ All trials have failed to date, more on-going
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Sachs NIF & JPM week presentation January 2026
Why does the company have confidence
in a positive phase 2b/3 trial outcome?
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1. Very strong cortisol scientific rationale in Alzheimer’s
2. Human PET study showing high brain target engagement (n = 40)
3. Large clinical benefit in pTau biomarker-positive Alzheimer’s patients (n = 34)
4. Clinically important activity of Xanamem on depression in phase 2 (n = 165)
5. Evidenced-based trial design & patient selection (n=247)
Sachs NIF & JPM week presentation January 2026
1. Very strong cortisol scientific rationale in Alzheimer’s
✓ Compelling evidence provided by the Australian Imaging,
Biomarker & Lifestyle Study of Ageing (AIBL) study (2017)1
• Higher plasma cortisol leads to a much greater risk of
developing AD
• Accelerated effect of Αβ+ on decline in global cognition,
episodic memory, and attention
✓ Individuals with the APOE-ε4 allele have higher CSF cortisol2
✓ Multiple other studies support the association between cortisol
and AD development and progression3-6
✓ High cortisol and low folate predict probable Alzheimer’s
disease after age 757
✓ Higher CSF cortisol levels in AD patients are associated with
more rapid clinical worsening and cognitive impairment8,9
9
[1] Pietrzak et al., 2017, Biol Psychiatry: Cognitive Neuroscience and Neuroimagery, [2] Lupien et al., 1998, Nat Neurosci 1:69–73; [3] Geerlings et al., 2015, Neurology 85: 1-8; [4] Lehallier et al.,
2016, JAMA Neurology 73(2), 203-212; [5] Popp et al., 2015, Neurobiol. Aging 36:601–607; [6] Ennis et al., 2017, Neurology 88(4):371-378; 2:45-52; [6] Lupien et al., 2009, Nat Rev Neurosci
10:434–445; [7] Hinterberger et al., J Am Ger Soc 2013 61(4):648-651; [8] Cernansky et al., 2006, Am J Psychiatry 163:2164-2169; [9] Kornhuber & Jensen, 2015, Neurobiol Aging 36:601-607;
Popp et al, 2015
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
Cognitive Normal MCI Other MCI AD AD dementia
CSF
cortisol
(μg/dl)
p<0.001
MEAN CSF CORTISOL LEVELS
Sachs NIF & JPM week presentation January 2026
Other 11β-HSD1 enzyme inhibitors have not achieved adequate brain levels
Xanamem extensively binds
to the 11β-HSD1 enzyme
throughout the brain, with
high post-treatment effects
(absence of color) after
7 days at all doses, slightly
less at a 5 mg dose.
This is consistent with full
hormonal pharmacodynamic
activity seen in clinical trials
with doses as low as 5 mg.
SUVRcarotid
5 mg Xanamem
Baseline After 7 days of daily dosing
10 mg Xanamem 20 mg Xanamem
2. Human PET study shows full target engagement
10
Journal of Alzheimer’s Disease 97 (2024) 1463–1475
Brain 11-Hydroxysteroid Dehydrogenase Type 1 Occupancy by Xanamem
Assessed by PET in Alzheimer’s Disease and Cognitively Normal Individuals
Victor L. Villemagne, Vincent Dor, Lee Chong, Michael Kassiou, Rachel Mulligan,
Azadeh Feizpour, Jack Taylor, Miriam Roesner, Tamara Miller and Christopher C. Rowe
Sachs NIF & JPM week presentation January 2026
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3. Large Xanamem benefit in high pTau181 patients
Phase 2a biomarker study: major slowing of CDR-SB decline over 12 weeks (n=34)
Journal of Alzheimer’s Disease 100 (2024) 139–150
Plasma pTau181 Predicts Clinical Progression in a Phase 2 Randomized
Controlled Trial of the 11-HSD1 Inhibitor Xanamem® for Mild Alzheimer’s Disease
Jack Taylor, Mark Jaros, Christopher Chen, John Harrison and Dana Hilt
0.36
0.98
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Baseline Week 12
Xanamem Placebo
0.6-point benefit @12 weeks
Xanamem vs. Placebo
• Mean 0.6 units
• Median 0.8 units
• p = 0.09
• Cohen’s d = 0.4
CDR-SB units
Change from
Baseline (SE)
Worse
performance
Sachs NIF & JPM week presentation January 2026
-12
-10
-8
-6
-4
-2
0
Baseline Week 2 Week 4 Week 6 Week 10
4. Durable activity of Xanamem 10 mg daily on
depression in phase 2
12
EOT 2.6-point difference
Cohen’s d = 0.38
p = 0.15
PT 4.2-point difference
Cohen’s d = 0.64
p = 0.03
Abbreviations: SSRI, selective serotonin reuptake inhibitor
MADRS
LS
mean
change
from
baseline
(±
SE)
Xanamem (n=37) Placebo (n=39)
ON TREATMENT AND BACKGROUND SSRI THERAPY (n=76)* FOLLOW
UP
BETTER
Sachs NIF & JPM week presentation January 2026
* Planned phase 3 population
Interim XanaMIA phase 2b/3 results in late Jan 2026, topline final results Nov 2026
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NIA-AA=National Institute of Aging - Alzheimer’s Association; CDR-SB Clinical Dementia Rating Scale – Sum of Boxes
40 Weeks
-4 0 36 Weeks
10mg Xanamem
Placebo
Screening
Double-blind, randomised treatment period (N = 247)
Follow-up &
open label
Key Inclusion Criteria Primary Endpoint Key Secondary Endpoints Implementation
• Blood pTau biomarker positive
• Mild-moderate Alzheimer’s by
NIA-AA criteria
• CDR-SB (functional and
cognitive measure) @36 weeks
• Cognitive Test Battery
(7 cognitive measures well-
validated in the Alzheimer’s field)
• Amsterdam Activity of Daily Living
(functional measure)
• Full enrolment at 15 Australian &
20 US sites of participants
• Interim analysis late Jan 2026
(efficacy futility & safety on all
available data)
• Final topline results Nov 2026
5. Evidence-based trial design & patient selection
Sachs NIF & JPM week presentation January 2026
XanaMIA interim analysis and open-label phase detail
Interim analysis late January 2026, open-label phase commences Q1 2026
Interim analysis of safety and efficacy futility
• Independent Data Monitoring Committee made up of experienced clinical and statistics experts
• Conducted in a highly confidential manner so that the company, investigators and trial personnel are kept
“blinded” to patient treatment assignment (active Xanamem vs. placebo)
• Uses data from all available participants and all completed visits at the time
• Outcome will be a binary recommendation to continue (trial not futile) or stop (trial is futile or there is
safety issue)
Open-label phase starting in Q1 2026
• Active Xanamem 10 mg offered to all current and prior XanaMIA phase 2b/3 trial participants
• No placebo control group
• Provides longer term safety data for at least 12 months and observational data on key efficacy endpoints
such as the CDR-SB, cognition and activities of daily living
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Sachs NIF & JPM week presentation January 2026
Strategic insights about commercialization
and partnering in AD
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1. Anti-amyloid infusions have a borderline risk-benefit profile and are expensive
2. Xanamem is being developed with a better risk-benefit and ease-of-use profile
aimed at stabilizing the disease safely
3. Desired Xanamem benefits include multiple aspects of cognition and life
functioning – ideally to halt Alzheimer’s decline completely
4. XanaMIA trial is a catalyst for commercial and partnering interest
Sachs NIF & JPM week presentation January 2026
-3
-2.5
-2
-1.5
-1
-0.5
0
0.5
donanemab all placebo all halt progression
Worsening of
CDR-SB
over 18 months
Modest benefit
of donanemab
(Kisunla) over
18 months
16
Worse
performance
Ideal trajectory
with disease
stabilization
Drugs targeting other mechanisms like Xanamem are needed
Unmet need
despite amyloid
therapy
1. Anti-amyloid drugs only modestly slow disease
Ideally patients with AD would not worsen on treatment at all
Sachs NIF & JPM week presentation January 2026
-3
-2.5
-2
-1.5
-1
-0.5
0
0.5
donanemab all placebo all halt progression
Worsening of
CDR-SB
over 18 months
Modest benefit
of donanemab
(Kisunla) over
18 months
17
Worse
performance
If results are good, Xanamem could be many times more effective than other drugs
2. Potential for Xanamem to beat existing approved
treatments on CDR-SB primary endpoint
Sachs NIF & JPM week presentation January 2026
e.g. Xanamem
approaches full
disease
stabilization over
18 months
18
Safety
• Well-tolerated
• No serious adverse events
related to Xanamem in whole
program to date (n ~ 500)1
3. Well-established safety and potential to see
consistent benefit on key secondary efficacy measures
1. No serious adverse events related to Xanamem have been reported across all clinical trials to date; various other safety data are reported in peer reviewed publications (see
https://actinogen.com.au/xanamem/
Sachs NIF & JPM week presentation January 2026
Key secondary endpoints
• Cognition
• Activities of daily living
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4. XanaMIA catalyst for commercial & partnering events
We know the commercial opportunity is huge:
✓ US Neurologists treating AD embrace the idea of a safe and effective, oral drug and indicate that
uptake would be rapid in the first year – anti-amyloid injectables have low market appeal
✓ Xanamem could easily move to first line therapy and displace many existing treatments
✓ Combinability with other small molecules and biologics a major plus
✓ Multiple potential commercialization partners are reviewing our confidential data
We are planning for:
✓ Completing one or more regional partnership deals if terms are favourable
✓ Final results that excite multiple, global partnership bids
✓ Final results that enable regulators to seriously consider expedited approvals
Sachs NIF & JPM week presentation January 2026
Conclusion
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Sachs NIF & JPM week presentation January 2026
Building momentum toward Alzheimer’s results
21
• Experienced team with proven track records
• On-track with XanaMIA pivotal trial for mild-moderate Alzheimer’s disease
✓ Full enrolment of 247 participants in XanaMIA achieved
✓ Interim results late January 2026, topline final results Nov 2026
• Highly positive market research with about 100 US Alzheimer’s physicians
✓ And 80% of physicians would prescribe Xanamem in the first 6 months
• FDA agreement on streamlined path to Xanamem approval
✓ One other pivotal trial of 10 mg vs. placebo, 1500 patients in total
• IP portfolio strengthened with the prosecution of multiple new patents
• Growing partnership awareness and interest in the program
• Company funded beyond mid 2026
Numerous value-add near-term milestones
Sachs NIF & JPM week presentation January 2026
Multiple near-term milestones in coming year
Milestone Likely Timing
Full enrolment, 247 patients with AD, XanaMIAAD trial Completed
XanaCIDD MDD peer-reviewed journal publication Q1 26
Meetings at JP Morgan Healthcare conference week, San Francisco Mid Jan 26
Interim analysis XanaMIAAD trial of all available data (weeks 12, 24 & 36) Late Jan 26
XanaMIAAD open-label extension (OLE) commences Q1 26
ADPD AD conference in Copenhagen Q1 26
EMA Scientific Advice meeting for AD Q2 26
Clinical Trials Science Forum Q2 26
BIO conference in San Diego Q2 26
AAIC AD conference in London Q3 26
Last patient completes 36-week treatment, 4-week follow-up Oct 26
Final topline results, XanaMIAAD trial Nov 26
XanaMIA topline results presentation at key AD scientific meeting Nov 26
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Sachs NIF & JPM week presentation January 2026
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Contacts
Michael Roberts
Investor Relations
P: +61 2 8964 7401
M: +61 423 866 231
E. michael.roberts@actinogen.com.au
Steven Gourlay
CEO & Managing Director
P: +61 2 8964 7401
E. steven.gourlay@actinogen.com.au
Join the Actinogen Investor Hub:
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